Wei Hao Secretary General China National Accreditation Board for Laboratories … · 2014-04-17 · 3 China National Accreditation Board for LaboratoriesChina National Accreditation

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China National Accreditation Board for LaboratoriesChina National Accreditation Board for LaboratoriesChina National Accreditation Board for Laboratories

Conformity Assessment System and Regulations of China

Wei HaoSecretary General

China National Accreditation Board for Laboratories (CNAL)


Outline• An overview of the Conformity Assessment

system in China

• Internationalized infrastructure for conformity assessment

• Regulatory conformity assessment programmes

• Regulations on conformity assessment activities

• Access to China market for foreign CABs

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Chapter 1

An overview of the CA system in ChinaAn overview of the CA system in China


An overview of the CA system in China

• Standards and Technical regulations

• Conformity assessment measures

• Standard and Conformity assessment bodies

• Laws and Regulatory Bodies

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Requirements on products :Standards

• National Standards ( approx. 21,000 Pcs)– Voluntary standards (approx.18,100 Pcs)

• Coded GBT-- XXX– Mandatory Standards (approx.2,900Pcs)

• Human health, safety and environment related • Coded GB—XXX

• Local Standards ( approx. 7,000 Pcs)• Voluntary and mandatory• Coded DB—xxx

• Sector Standards (approx. 28,000 Pcs)• Published by Ministries or professional bodies

• Company Standards ( approx. 600,000 Pcs)• Should be registered


Technical Regulations• Usually not directly for product

requirement

• Always adopt relevant standards ( usually mandatory standards)

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Conformity assessment measures

• Manufacturers Declaration – For conformity with non-compulsory

standards• Market surveillance inspection and

testing done by regulatory bodies• Product certification• License to Manufacturers or products


Conformity Assessment Bodies

• Product Quality Testing Centers– National level ( approx. 300)– Provincial or Ministerial level ( approx.1000)

• Regulatory authorities– Commodity Inspection and Quarantine (CIQ)– Quality and Technical Supervision Bureau ( CSBTS)

• Third party certifiers – For Voluntary programmes– Mostly government owned

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Related laws and Regulations

• Law on Product Quality• Law of P.R.China on the on the Entry-Exit

Animal and Plant Quarantine• Law of P.R.China on the Import & Export

Commodity Inspection• Law on Metrology• Food Hygiene Law of P.R.China • Regulations of P.R.China on Certification

and Accreditation


Regulatory Bodies• General Administration of Quality Supervision, Inspection and

Quarantine ( AQSIQ)

• China National Administration for Certification and Accreditation (CNCA)

• Standardization Administration of China (SAC))

• Ministry of Health ( food and medicine etc.)

• Ministry of Information Technology

• Ministry of Public Security ( fire proof products and others)

• Other Ministries

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Chapter 2

Internationalized infrastructure for conformity assessment


Building up an Internationalized infrastructure

• Since late 1980’s ,China has been putting effort to build up an Internationally recognized conformity assessment infrastructure to meet the needs of market oriented economy

• The system is now recognized by the international community and ready to be used by industries and the government

• China began to regulate the conformity assessment activities in order to make a better use of this infrastructure

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Conformity Assessment Hierarchy

Reports and Certificates

COOPERATIONILAC

MUTUAL RECOGNITION APLAC & EA

GOVERNMENT (CNCA)Authorizes Accreditation Bodies

ACCREDITATION BODIESISO/IEC Guide 58 and Guide 61 and ISO/IEC 17010→ISO/IEC 17011

COOPERATIONIAF

MUTUAL RECOGNITION EA & PAC

LABORATORIESTest and Certify

Items and MaterialsISO/ICE 17025

SYSTEMS CERTIFICATION BODIECertify Quality and Environmental

Managenent SystemsISO/IEC Guide 62

INSPECTION BODIESInspect and Certify

Items,Materials, ProcessesISO/IEC 17020

PERSONNEL CERTIFICATIONBODIES

Certify Systems Auditors ISOIEC17024

PRODUCT CERTIFICATION BODIESLicense Products to use

A Certification MarkISO/IEC Guide 65

PRODUCTSMarked to Comply

Specification/Safety Requirement

MANAGEMENT SYSTEMIs Certified

ISO 9001& ISO 14001

SYSTEMS AUDITORSCertified to Audit

Various Standards

AN ITEM OR MATERIALIs Certified

Standards/Specifiqations

ITEM,MATERIAL,PROCESSIs Certified

Standards/Specifiqations

USERS AND CONSUMERSHave Assurance


Accreditation

“Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks”

(ISO/IEC Guide 2:1996)Key words: “competent”

“specific tasks”

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Accredited CABs• Conformity Assessment Bodies ( CAB’S)

– Certification Bodies certifying • Management Systems

– Quality Management System– Environment Management System– HACCP– Occupational Health Management System

• Product • Personnel • Training Course Providers

– Laboratories– Inspection Bodies


Accreditation Bodies• Authorized and supervised by CNCA

• Running accreditation system based on international standards or Guides

• Entered into international Mutual Recognition Arrangements

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Accreditation bodies in China

• China National Accreditation Board for Laboratories (CNAL)

• China National Accreditation Board for Certifiers (CNAB)

• China National Auditor and Training Accreditation Board (CNAT)


China National Accreditation Service (CNAS)China National Accreditation Service (CNAS)

CorporateCorporateDepartmentDepartment

BOARDBOARDCNALCNAL

BOARDBOARDCNABCNAB

BOARDBOARDCNATCNAT

SecretariatSecretariatCNALCNAL

SecretariatSecretariatCNABCNAB

SecretariatSecretariatCNATCNAT

CNAS

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CNAB Accredits• Management System Certification

– Quality Management System– Environment Management System– HACCP – Occupational Health Management

System• Product Certification


CNAB Updates

• Accredited Management System Certification bodies(by Sep. 1st, 2004)

• Accredited Product Certification bodies(by Sep. 1st, 2004)

– 24

7445367HACCPOHSMSEMSQMS

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CNAT Accredits?• Auditors

– QMS、EMS、OHSMS、HACCP• Training Course Providers

– QMS、EMS、OHSMS


CNAT Updates• Registered auditors (by Sep. 1st, 2004)

• Accredited Training Course Providers(by Sep. 1st, 2004)

79256241430844874HACCPOHSMSEMSQMS

101521

OHSMSEMSQMS

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CNAL Accredits?

• Testing Laboratory– Medical Laboratory– Bio-safety

• Calibration Laboratory• Inspection Body• Proficiency Testing Provider


China National Accreditation Board for Laboratories

CNAL

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Organizational Structure of CNAL

Board

AppealsCommittee

Decision Committee

Secretariat

Technical Committee

Executive Committee

… Sub-TC

… Sub-TC

…Sub-TC

… Sub-TC

… Sub-TC

Assessors Qualification Division

PD and PT Division

Accreditation Assessment Division

General Affairs Division


Mission of CNALTo raise awareness of and to promote laboratory accreditation in ChinaTo set up and implement a national voluntary accreditation scheme on the basis of national or international standards/Guides for :

Laboratories (Calibration and Testing)Inspection bodies

To undertake other mandatory laboratory evaluation works on behalf of relevant government bodiesTo provide technical support to the governmentTo participate in international cooperation

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Accreditation Scopes of CNAL

• Biology • chemistry• electricity • mechanics• non-destructive

testing • optics• acoustics and

vibration

Testing•electromagnetic compatibility•animal/plant quarantine•medical quarantine•light industry products•textiles-clothing-leather products•metallurgy, metallic/nonmetallic mineral products and etc.


Accreditation Scopes of CNAL

• Heat calibration thermology

• Mechanical• Electromagnetic • Dimensional • Optical

Calibration

•Chemical •Ionizing•Radio •Acoustic •Time frequency calibration

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Updates of CNALAs of November 12 2004• accredited laboratories :

– 1707• accredited inspection bodies:

– 26• increasing rate:

– about 30% per year• registered assessors :

– 2186• registered technical experts :

– 2174


International Cooperation of CNAL

• Funding member of ILAC and APLAC• Signed MRAs

– Renewed its MRA Signatory status within APLAC &ILAC in 2003 for testing and calibration areas

– is going to enter into APLAC MRA for IB shortly ( peer evaluation completed)

• Hosted APLAC meetings• Organized PT Programs for APLAC• Chair the Training Committee

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Use of Laboratory Accreditation

• How Chinese government uses lab accreditation:– 3C certification must use CNAL accredited

lab– all national testing center for product

quality must be accredited– all CIQ laboratories will be accredited– laboratories undertaking testing for

defense industry must be accredited


Certification

• Voluntary Sector– Management system Certification– Some Product Certification

• Some new programs are developed according to ISO Guides

• Still many programs are not based on internationally accepted standards or practices

• Accreditation is not involved in many cases

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Voluntary certification• Product certification

– Certificates issued 11,629– CB’s involved 46

• Management systems certification – QMS Certificates 132,891– EMS Certificates 8849– OHSMS Certificates 3589


Certification• Regulatory schemes

– Mostly on product– Complicated situation

• 3C Certification • QS marking for food• Animal Feed Approving • Quality licensing for some industrial product

manufacturers• Quality licensing for some exporting enterprises• ……..

– Operated by different Ministries or Provincial Governments

– Accreditation is not applied in many programs

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Testing laboratories•• 20,000 20,000 testing labs providing public testing labs providing public

services for product testing services for product testing

•• Over 30,000 medical testing laboratoriesOver 30,000 medical testing laboratories

•• Many other competence assessment Many other competence assessment programs except accreditationprograms except accreditation


Calibration Labs•• Approx.3,000 public labs in ChinaApprox.3,000 public labs in China

•• Most of them are legal metrology verification Most of them are legal metrology verification bodiesbodies

•• Only 200 more are accredited Only 200 more are accredited

•• All of them are approved by Metrology All of them are approved by Metrology regulatorsregulators

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Inspection Bodies•• More than 2,000 Independent Inspection More than 2,000 Independent Inspection

bodies for bodies for –– Boiler and pressure vesselsBoiler and pressure vessels–– Commodity inspection Commodity inspection –– Ship inspectionShip inspection–– Factory inspection Factory inspection –– Building and constructionBuilding and construction

•• Mostly in regulated areaMostly in regulated area


Chapter 3

Regulatory Conformity Assessment Programmes

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Regulatory programmes•• CCC markingCCC marking

•• CIQ Inspection on import and export CIQ Inspection on import and export commoditiescommodities

•• Licensing to industrial productsLicensing to industrial products

•• Market surveillance inspection and testingMarket surveillance inspection and testing

•• othersothers


China Compulsory Certification --CCC

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Products Subject to Compulsory Certification

• Health and safety of human beings• Life safety of animals and plants

• Environmental protection• Public security• National security


Catalogue of Products Subject to Compulsory Certification

• Total 20 categories (in 9 sectors)– Electric and Electronic appliances– Telecommunication equipment– Vehicles and motorcycles– Safety glass– Fire-fighting equipment– Fire and burglary detectors– Agricultural machinery– Rubber products – Tires

• 139 product items

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Compulsory Product Certification

• Catalogue of products subject to CCC Certification– Formulated and adjusted by CNCA jointly with the

relevant departments of the State Council– Mostly on consumer products– 139 items covered at present and to be expanded

• For those products also listed in the Catalogue of import-export commodities subject to compulsory inspection, the inspection shall be simplified


Kernels for Compulsory Product Certification System

• Products in the Catalogue must be certified by certification bodies designated by CNCA.

• Products must obtain the certificate and be applied the certification mark

Products made inside China be applied with mark before release from factory

imported products be affixed with mark before entry into China.

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Models of Certification• type test• testing or inspection of samples taken from the

factories• testing or inspection samples taken from the

market• assessment of manufacturers’ quality

assurance system• regular follow up inspection on certified

products


Procedures for Certification

1. Application and acceptance 2. Sampling and testing3. Initial factory inspection4. Evaluation and approval on

certification results5. Follow up inspection

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CCC --Statistics• Certificates issued 152,296

– Domestic 140,504– Abroad 11,792

• Manufactures certified 32,108– Domestic 29,939– Abroad 2169

• Number of labs used 115• Number of CBs designated 12


Inspection on import and export Commodities

• Catalogue of imp. & exp. commodities subject to compulsory inspection by CIQ– Promulgated by General Administration of Quality

Supervision, Inspection and Quarantine of P.R.China (AQSIQ)

– 3339 product items subject to importing inspection– 4059 product items subject to exporting inspection– Inspection is carried out by local CIQ Authorities

For details: http://www.aqsiq.gov.cn

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Registration of food exporters and manufacturers

• Catalogue of food exporters and manufacturers subject to registration is established by CNCA

• Manufacturers of food within the catalogue shall be registered with and supervised by CNCA ( 11,225 companies registered by now)

• For details:http : // www.cnca.gov.cn


Licensing to Product manufacturers

• 86 categories of product are subject to Manufacture licensing issued by AQSIQ– Equipment for industrial use– House holds products

• Procedures– Products be tested – Factories be assessed

• Overlaps with CCC for some products

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Market surveillance inspection and testing

• Conducted by local CSBTS under direction of AQSIQ

• No limit for product selection• Products are sampled from market or

manufacturing site• Designated CABs are used usually accredited labs• Results are published • Those who fail the test may be punished


Other compulsory programmes

• Compulsory inspection on Special equipment– Boilers, pressure vessels, pipeline– Lifts, cranes, outdoor entertainment equipment– Etc.

• Compulsory inspection on medicine and medical apparatus

• Compulsory certification and inspection on Metrology instruments

• Compulsory inspection on auto vehicles

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Chapter 4

Regulations on conformity assessment activities



• “ Regulations on Certification and Accreditation” came into effect in November 2003

• This regulation will help to apply the international requirements to the existing conformity assessment programmes

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Regulations on certification and accreditation

• The regulations require Certification Bodies

– Be approved by CNCA– Shall have adequate facilities – Shall have effective management system– Shall have more than 10 permanent staff– Shall have registered capital no less than 100,000 RMB– Be accredited if undertake mandatory certification

programme



• The regulations require laboratories and inspection bodies providing data or results for public use

– Be verified and approved for its competence

– Be accredited if undertake testing for mandatory certification programmes

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The regulation require– To formulate a unitary accreditation system so

that there is no overlap in accreditation

– Accreditation bodies be authorized by CNCA

– Accreditation bodies implement effective quality system to ensure integrity of the accreditations


Effects of the new regulations– To encourage internationally accepted

practice in conformity assessment activities especially in regulatory area

– To use more accreditation as a means of competence demonstration

– To enhance the quality and integrity of conformity assessment activities

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Chapter 5

Access to China MarketFor Conformity Assessment Bodies & results


Foreign investment in CBs and Testing Labs in China

• From December 11 2003 to December 10 2005– Only joint venture is permitted – Foreign investors may hold over 51% shares

• From December 11 2005 onward– Sole foreign investment will be allowed

• The foreign investors should have more than 3 year’s experience in the area concerned

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Conditions for Foreign-fundedCB in China

• Requirements for CB– Fixed premises and necessary facilities– Management system required– Registered capital of RMB3,000,000( about USD

360,000)– 10 full-time certification personnel in relevant fields

• Requirements for foreign investor :– is accredited by national or regional AB– engaged in certification activities for 3 years minimum

• Other requirements of law, administrativeregulations and provisions on foreign investment apply


Acceptance of Accreditation by MRA Signatories

• Is very limited by regulators– Most of regulatory testing or certification

are carried out by designated bodies– Accreditation is usually not the only

condition for designation– In many cases accreditation is not even a

condition for designation

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Acceptance of Accreditation by MRA Signatories

• In the case of CCC marking– Foreign testing report can be accepted when

• The lab is accredited by a MRA member body• A bilateral agreement between two

governments exists• Under the IEC CB scheme

• In the case of Import Inspection– Foreign testing report is accepted only based

on government to government agreement


The way ahead

•• The trend of CA activities in ChinaThe trend of CA activities in China

–– More international standards adoptedMore international standards adopted–– CA procedures become closer to CA procedures become closer to

internationally accepted standardinternationally accepted standard–– Accreditation will be more widely used Accreditation will be more widely used –– Better accessibility to foreign CABsBetter accessibility to foreign CABs

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Summary•• China is aligning its conformity assessment system with China is aligning its conformity assessment system with

international standards and practicesinternational standards and practices

•• Existing regulatory conformity assessments system needs to be Existing regulatory conformity assessments system needs to be improved or reformedimproved or reformed

•• Voluntary conformity assessment programs are encouraged to be Voluntary conformity assessment programs are encouraged to be developed and serve in the marketdeveloped and serve in the market

•• The conformity assessment infrastructure meeting international The conformity assessment infrastructure meeting international requirements has been build up and is growing fast and will be requirements has been build up and is growing fast and will be better usedbetter used

•• The new regulations will speed up the process of reforming The new regulations will speed up the process of reforming


Any Questions?

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THANK YOU ！

Documents

Wei Hao Secretary General China National Accreditation Board for Laboratories … · 2014-04-17 · 3 China National Accreditation Board for LaboratoriesChina National Accreditation